Senior Process Engineer, Oral Solid Dose Scale-Up

Allergan; North Chicago (IL); On-site; USD 150,000 - 240,000; Full time

Benefits offered by this job

Comprehensive benefits package

Long-term incentive programs

401(k)

Job summary

AbbVie seeks a senior process engineering leader to drive late-stage development, scale-up, validation, and commercialization of oral solid dosage products. You will apply DoE/QbD and modeling to develop robust processes, establish control strategies, and support regulatory submissions across cross-functional teams.

You will lead technology transfer, PPQ, and process characterization from lab to commercial sites, ensuring lifecycle management while complying with GxP and company standards.

Qualifications

• Bachelor's degree with typically 12 years, Master's with typically 10 years, or PhD with typically 4 years of relevant experience.
• Theoretical and practical understanding of pharmaceutical process engineering principles.
• Experience in oral solid dosage form development and commercialization.
• Experience scaling manufacturing processes from lab to commercial production.
• Experience leading technology transfer across manufacturing sites.
• Knowledge of DoE, QbD, PPQ and process validation principles.
• Strong written and verbal communication for regulatory documentation, CTD submissions.
• Ability to influence cross-functional teams and drive project execution.

Responsibilities

• Lead scale-up of oral solid dosage processes from pilot to commercial manufacturing.
• Develop and execute technology transfer strategies for internal and external sites.
• Apply experimental design and modeling to support process development and scale-up.
• Establish scientifically sound process control strategies and critical parameters.
• Lead process characterization, PPQ, and validation activities for product commercialization.
• Author and review regulatory CMC documentation, including CTD Module 3.2.P.2.3.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, and Technical Operations.
• Adhere to GxP, safety, and company code of conduct.

Skills

Process engineering

DOE

QbD

Regulatory documentation

Cross-functional leadership

Tech transfer leadership

Education

Bachelor's degree in Pharmaceutical Sciences or related field

Master's degree in a related field

PhD in a related field

Job description

AbbVie seeks a senior process engineering leader to drive late-stage development, scale-up, validation, and commercialization of oral solid dosage products. You will apply DoE/QbD and modeling to develop robust processes, establish control strategies, and support regulatory submissions across cross-functional teams.

You will lead technology transfer, PPQ, and process characterization from lab to commercial sites, ensuring lifecycle management while complying with GxP and company standards.